The present invention generally relates to an automatic analysis apparatus, and more specifically, is related to an automatic analysis apparatus suitably for measuring the same analysis item in a plurality of measuring channels with respect to a large number of samples, is also related to a managing apparatus, and a program product for managing data quality of the analysis apparatus.
Very recently, strong needs are made in automatic analysis apparatuses. That is, since processing capabilities of such automatic analysis apparatuses are wanted to be increased, a large amount of samples can be analyzed within a short time period. Under such a circumstance, the following automatic analysis apparatuses have been marketed in which a plurality of analysis modules are connected so as to measure reaction fluids, while pipetting both reagents and samples into reaction containers.
As automatic analysis apparatuses, there are biochemical analysis apparatuses, immunity analysis apparatuses and so on. As analysis items of a biochemical analysis apparatus, cholesterol density (concentration) contained in a blood sample is measured, either a GPT value or a blood sugar level contained in a blood sample is measured, and protein density contained in a urine sample is measured. Such an analysis is carried out as follows. That is, for instance, while a sample to be measured and a preselected reagent are put into a reaction container, both the sample and the reagent may cause opto-chemical reaction, so that a photodetector may detect an amount of specific light emitted from this opto-chemical reaction, or a spectral analyzer analyzes a spectrum of light which passes through the reaction fluid. Then, an electric signal produced from the photodetector is converted into density values of analyzed components by using a calibration curve. An automatic analysis apparatus is capable of measuring a plurality of these analysis items in a continuous manner as to an individual sample of large amounts of samples.
In this case, precision in the respective elements employed in such an automatic analysis apparatus, for instance, pipetting of the sample/reagent and detections of the electric signals from the reaction fluid, could give adverse influences to the measurement values. As a result, if the route paths of the automatic analysis apparatus defined from pipetting of the sample/reagent up to measuring of the reaction fluid are made different from each other, then the resultant measurement data may contain a difference caused by the route paths of analysis through which the measurement data are obtained even when the same analysis item is measured.
As explained above, when a plurality of measurement data about the same analysis item are acquired via the different route paths, the respective route paths are called as “measurement channels” which are discriminatable.
In the above-explained automatic analysis apparatus in such a case that a plurality of different analysis items are analyzed within one time, the different, or separate analysis items may be allocated to the respective measurement channels. Alternatively, a large sampling number of analysis items may be shared by a plurality of measurement channels so as to be measured. Conventionally, the calibration results and the quality control results for data accuracy and reliability are separately managed with respect to each of these measurement channels in the automatic analysis apparatuses.
A calibration is obtained in the form of either a calibration curve or line in such a manner that while two or more samples having known different densities of a component are analyzed by an analysis apparatus, a relationship between analysis output signals and the known density values is expressed as such a calibration curve, or a calibration line. A quality control is utilized so as to maintain measurement precision and reliability of an analysis apparatus in such a manner that while a sample having known density is measured by the analysis apparatus for either a constant time period or an irregular time period, measurement data acquired in a time sequential manner are processed by way of the statical manner so as to detect a data variation and a data fluctuation.
In the automatic analysis apparatus described in JP-A-10-2902, at least two sets of the analysis items of the measurement samples and also the information related to this analysis item are displayed on a single screen by the information display management means, so that a plurality of information can be confirmed within one time.
In an automatic analysis apparatus equipped with a plurality of measurement channels, more specifically, even in such an automatic analysis apparatus for measuring the same analysis item in a plurality of measurement channels, the individual equipped measurement results can be considered as the measurement result acquired from a single automatic analysis apparatus. In other words, even when the same analysis item is measured by any of the measurement channels, it is important to obtain measurement data having a same accuracy level.
To this end, the respective measurement channels for measuring the same analysis item must be maintained under same measurement precision condition. This measurement precision may be similarly applied to such a case that a single analysis module is equipped with a plurality of measurement channels.
For example, there is a system wherein a pipetting mechanism of a sample and a pipetting mechanism of a reagent are commonly used in different channels, and while different detection units are used for the channels. There is another case that different pipetting mechanisms of a sample, or a reagent are used, and while a single signal detecting unit is commonly used in different channels.
In the case that the same analysis item is measured by such plural measurement channels, the calibration is individually, or separately carried out as to the respective measurement channels. When the calibration results of this same analysis item are managed every measurement channel, for example, even if the data about the calibration results for a plurality of different analysis items measured in this measurement channel are collected and then are displayed on the screen, this display method is not suitable for systematically grasping both the measurement precision and the measurement reliability of the same analysis item as the entire analysis apparatus. In other words, this display method is not proper when measurement precision of a certain measurement channel is compared with that of another measurement channel. Moreover, confirmations of the calibration results of a plurality of measurement channels may become cumbersome. This cumbersome confirmation may cause the work load of the user to be increased, while a total number of measurement channels is increased.
Similar to such a quality control executed in the case that measurement data are acquired from a single measurement channel, a quality control must be carried out as follows. That is, in addition to a quality control executed in an individual measurement channel, various measurement data are gathered together as a single measurement data group without being discriminated from each other. These measurement data are acquired from the respective measurement channels through which the same analysis item is measured by using each of these analysis modules, or the entire analysis apparatus.
As a consequence, such a confirmation can be made as to such a case that although the quality control data of each of the measurement channels may satisfy the allowable value of the quality control, such quality control data obtained by combining the measurement data of the plural measurement channels cannot satisfy the allowable value.
In the automatic analysis apparatus described in JP-A-10-2902, the measurement data of the plural measurement channels may be displayed on a single screen.
However, in such a case that even when the quality control data may satisfy the allowable range, the quality control data as the entire analysis apparatus cannot satisfy the allowable range, this automatic analysis apparatus cannot automatically judge this quality control data. As a consequence, the quality control as the entire automatic analysis apparatus can be hardly realized.
If the calibration information of the respective measurement channels could be displayed as a list in combination with the above-explained quality control information, then such information by which the user of the automatic analysis apparatus can judge the conditions of the respective measurement data could be provided within one time. As a result, the user can easily grasp the conditions of the automatic analysis apparatus.